China's First Homegrown Radiopharmaceutical Receives Dual FDA Breakthrough Therapy and Fast Track Designations
On August 6, Nuoyu Medical announced that the U.S. Food and Drug Administration (FDA) has officially granted Breakthrough Therapy Designation (BTD) and Fast Track Designation (FTD) to the company's independently developed 68Ga-NYM096. This marks the first product in China's original radiopharmaceutical field to receive FDA Breakthrough Therapy Designation, and the first to receive both FDA Breakthrough Therapy and Fast Track designations simultaneously, creating a milestone breakthrough in the radiopharmaceutical field. 68Ga-NYM096 is a small-molecule diagnostic radiopharmaceutical for renal cancer that specifically binds to CAIX, suitable for positron emission tomography (PET) imaging of suspected or confirmed metastatic clear cell renal cell carcinoma (c...
2026-08-08
